University of Kansas

PRINCETON, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced it will host a virtual key opinion leader (KOL) event on Wednesday, November 20, 2024 at 2:00 PM ET. To register, click here. The event will feature Abhishek Ray, MD (University Hospitals) and Andrew Webb, PharmD, BCCCP (Massachusetts General Hospital), who will discuss the high unmet medical need and current treatment landscape for patients suffering from aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency. A live question and answer session will follow the formal presentations. About Abhishek Ray, MD Abhishek Ray, MD, is a fellowship-trained, board-certified neurological surgeon at University Hospitals and Associate Professor of neurological surgery at Case Western Reserve University School of Medicine. He specializes in caring for people with cerebrovascular disease (brain aneurysms, stroke, AVMs), pituitary tumors and meningiomas, and in minimally invasive techniques to treat degenerative spine disease. In neurological surgery, there are often multiple ways to treat a single problem, and Dr. Ray is committed to providing each patient with an individualized care plan to optimize results. In 2021, 2022, 2023, and 2024, he was selected by his peers to be included in Cleveland Magazine’s list of Top Doctors. After completing his undergraduate degree in biological systems engineering at the University of California – Davis, Dr. Ray went back to his hometown to attend medical school at the University of Kansas School of Medicine in Kansas City, Kansas, where he was elected to be an ambassador of the school and was inducted into the Alpha Omega Alpha Honor Medical Society. He then went on to complete neurological surgery residency at University Hospitals/Case Western Reserve University School of Medicine, where he also completed fellowship training in neuro-interventional surgery. Dr. Ray stayed on as faculty at UH/Case Western Reserve University School of Medicine to advance neurosurgical education there. He created a unique and comprehensive neurological surgery elective for second-year medical students, of which he is now the course director. He has been an instructor at national skull base courses for neurosurgical residents and fellows and has served as editor of the neuro-interventional section of CNS Nexus, an online library of neurosurgical cases to better prepare trainees for the operating room. About Andrew Webb, PharmD, BCCCP Andrew Webb, PharmD, BCCCP, is a board-certified neurocritical care clinical pharmacy specialist at Massachusetts General Hospital (MGH) and serves as adjunct clinical faculty at Northeastern University School of Pharmacy and Pharmaceutical Sciences. His clinical and research interests include subarachnoid hemorrhage, status epilepticus, traumatic brain injury, and optimizing the medical management of neurocritically ill patients and his clinical practice is on the multidisciplinary neurocritical care team at MGH’s 22-bed neurosciences intensive care unit. Dr. Webb is originally from Rhode Island and completed his undergraduate studies and Doctor of Pharmacy at the University of Rhode Island. He then completed his pharmacy practice residency at Mayo Clinic in Rochester, MN followed by residency in critical care at Oregon Health & Science University in Portland, OR. Dr. Webb serves on the MGH Comprehensive Stroke Center Quality Taskforce and the MGH Neurology Quality Assurance and Committee on Patient Safety, focusing on improving the quality, safety, and effectiveness of medication therapy in stroke, subarachnoid hemorrhage, and other neurologic conditions. He is active in the Neurocritical Care Society, American College of Clinical Pharmacy, and Society for Critical Care Medicine and serves on several committees within these organizations related to critical care and neurology practice, research, and education. He has lectured regionally and nationally on the pharmacotherapy of subarachnoid hemorrhage, status epilepticus, and the unique challenges of pharmacotherapy in neurocritical care. About aneurysmal Subarachnoid Hemorrhage (aSAH) aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in the United States are affected by aSAH per year, based on market research. Outside of the United States, annual cases of aSAH are estimated at approximately 60,000 in the European Union, and approximately 150,000 in China. About the Grace Therapeutics Asset Portfolio GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTx-104 is estimated to be about $300 million, based on market research. GTx-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTX-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. The further development of GTx-102 has been deprioritized in favor of our focus on development of GTx-104. It is also possible that we may license or sell our GTx-102 drug candidate. GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (PHN). GTx-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, we believe that the biphasic delivery mechanism of GTx-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTx-101 has been deprioritized in favor of our focus on development of GTx-104. It is also possible that we may license or sell our GTx-101 drug candidate. About Grace Therapeutics Grace Therapeutics is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’s novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutics’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’s lead clinical asset, GTx-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: www.gracetx.com. Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates", "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the timing of a data readout from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, the timing of the Company’s planned NDA submission with the FDA in connection with the Company's Phase 3 STRIVE-ON safety trial, GTx-104’s commercial prospects; the size of the addressable market for GTx-104, the Company’s beliefs regarding the potential benefits of GTx-104, including GTx-104's potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated benefits and future development, license or sale of the Company's other drug candidates are based upon Grace Therapeutics's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTx-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Grace Therapeutics's clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Grace Therapeutics from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Grace Therapeutics Contact: Prashant KohliChief Executive OfficerTel: 609-322-1602Email: info@gracetx.com www.gracetx.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com

BARGERSVILLE, Ind., Sept. 16, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Paul Delbert Winchester, MD is acknowledged as a Top Pinnacle Neonatologist for his contributions in Neonatology. Dr. Winchester, an esteemed neonatologist with a career spanning over four decades, has made significant contributions to the field of neonatology and pediatric care. His dedication to the well-being of infants and children has earned him recognition as a leading expert in the field. Continue Reading Paul Winchester Currently serving as the Professor of Neonatology at the Riley Hospital for Children at Indiana University Health in Indianapolis, and attending Neonatologist at St. Francis Hospital, Indiana, Dr. Winchester has been at the forefront of neonatal acute care since 1981. Dr. Winchester is renowned for his innovative and comprehensive approach to clinical care. His emphasis on understanding patients' medical histories and a strong focus on preventive measures has set him apart as a practitioner who goes above and beyond to ensure the well-being of the young patients under his care. His educational journey began with a Bachelor of Arts in experimental psychology from Stanford University in 1970. He continued to excel academically, earning a Master of Arts from the University of Michigan in 1972 and a Doctor of Medicine Internship and Residency in pediatrics in 1979, and Fellowship in Neonatology 1981 at the University of Colorado Medical Center in Denver. The board-certified physician is a Fellow of the American Academy of Pediatrics and is currently affiliated with Indiana University School of Medicine as a Clinical Professor and Riley Hospital, Eskenazi Hospital, Francis Hospital, Indianapolis, as medical staff. The doctor is board-certified in pediatrics and neonatal and perinatal medicine; is a PALS provider; and is an NRP Instructor/provider. Throughout his career, Dr. Winchester has achieved several remarkable milestones. Notably, he holds the distinction of being the first neonatologist to practice outside of Denver, Colorado. He developed the first Level III NICU outside of Denver in Colorado in 1981, which tripled survival rates in very low birth-weight babies in 6 months; developed Neonatal Nurse Practitioner Program with Marsha London, RN at Beth-El School of Nursing, Colorado Springs; was a member of the First Neonatal Transport Team for Fort Carson Army Mast Helicopters, as well as Mayo Fixed Wing medical transports; Neonatal Fellowship (Beth Murdoch) program with Bill Haye, MD CUMC; Resuscitation and intubation labs for Southern Colorado Family Practice Program in Pueblo, Colorado. Dr. Winchester has made several significant contributions to the field of neonatology making him a world-renowned physician. Dr. Winchester developed the first High Frequency Ventilator in Colorado with designs incorporated into commercial HFJV now in use; introduced High Frequency Ventilation to Colorado, Kansas and New Hampshire; was awarded a March of Dimes grant to begin the first Prematurity Prevention Program in Colorado in 1982 along with Maria Carlos and Robert Creasy MD; had the first reported use of prenatal steroids in preterm labor mothers <28 weeks gestation, which doubled survival rates and cut severe IVH rates in half; was the first to use post-natal steroids to treat BPD in Colorado which was adopted by Gordon Avery Washington Children's Hospital; helped develop ultrasound as a diagnostic test for neonatal intraventricular hemorrhage along with Carol Rumack, MD; developed clinical care flow sheet which is under the Baby's Benefit copyright; and discovered that preterm birth is heritable. Dr. Winchester adds that he developed Paul's three rules: 1) if you have it you've always had it 2) if you have it, your family has it 3) if you have it you "marry" it, (choices of place to live, place to work, profession, likes and dislikes, are all informed by your genome). Among his great accomplishments, Dr. Winchester, along with colleague Rodney Levine NIH, is credited with making the groundbreaking discovery in Kansas City that a phenol-based germicide used to clean bassinets was a cause for newborn jaundice. He also organized mentorship programs for Blue Valley High School and Shawnee Mission School District and entered into a congressional agreement with manufacturers (Merk) to not market to newborn care facilities. In New Hampshire, he discovered that prenatal steroids influence the post-menstrual day of discharge from the NICU by accelerating physiological maturity with Robert Darnell Dartmouth Medical Center. During his time in Indiana the doctor discovered that the two leading causes of Infant Death (birth defects and preterm birth) both peak in the months of peak pesticides in US surface waters and went on to discover that 93-99% of pregnant Hoosier mothers are exposed to the weed killer glyphosate (GLY) (aka Round Up), and that higher levels of glyphosate shorten pregnancies, which leads to premature birth in some and reduces fetal growth. After Winchester and colleagues finding that a majority of US Women are exposed to glyphosate, the CDC and other investigators confirmed the findings and added additional adverse effects to the list including the additional impact of AMPA (the main metabolite of glyphosate) , masculinization of female genitals and predisposition to fatty liver disease. With collaborator Mike Skinner from WSU, Dr. Winchester found that GLY induces epigenetic changes in exposed offspring which translated into "heritable" diseases such as obesity, perinatal mortality, and multiple disorders and has contributed numerous abstracts and presentations for more than 20 years to the annual Academic Society for Pediatrics, formerly SPR. He has a plethora of grants that have made much of his research possible. Dr. Winchester's work history includes serving as the Director of Neonatology at Memorial Hospital in Colorado Springs from 1981 to 1990 and a faculty role at the University of Colorado, where he shared his expertise by teaching clinical pediatric coursework from 1985 to 1986. He has more than 40 years practicing in Neonatology, founding two level III NICUS at Memorial Hospital in Colorado Springs, Colorado and Overland Park Regional Medical Center in Kansas where he directed four NICUS including one at Elliot Hospital, NH and St. Francis Hospital, IN. He is an esteemed member of numerous professional organizations, including the American Academy of Pediatrics where he is distinguished as a Fellow; District VIII Perinatal Medical Society; Subspecialty Board Neonatology at the American Academy of Pediatrics; and was a clinical instructor at the Department of Pediatrics at the University of Colorado and the University of Kansas (KUMC). Dr. Winchester has also received numerous distinctions and awards during his illustrious career including: Stanford Management Intern (SNIP) of the Year Award in 1968; graduated with honors from Stanford University in 1970; is a recipient of the Franklin P. Gengenbach Award for Best Pediatric Student in 1974-1975; March of Dimes "Make a Difference" Award in Greater Kansas City in 1991; Red Shoes Award at Riley Hospital in 2005; Indiana Public Health Association's Tony and Mary Hulman Achievement Award for Health Science Research in November 2013. The Top Doc Award in the Indianapolis Monthly Magazine in 2014, 2016-2021; Castle Connolly Top Doctor Award in 2016. Dr. Winchester is a highly sought-after professional and expert in the field and has served in many other capacities during his career including being a member of the NAS Multi-disciplinary Task Force at St. Francis Medical Center; founded and supported the Annual Perinatal Conference "Growth and Challenge" in Colorado Springs, Colorado; and supported as Clinical Advisor Research Fellowship by Amira Bastawisi, MD-Risk Factors for Premature Birth in Colorado Research tool developed by P.S. Winchester and Elizabeth Kyre. He has been an invited lecturer at numerous conferences including The Iowa Governor's Conference on Public Health where he was the keynote speaker and the Indianapolis Healthy Babies Consortium Meeting as a featured speaker. As a renowned researcher, with presentations from 2001-2024 at annual Academic Pediatric Society Meetings. Dr. Winchester has countless IRB's adding to the body of work supporting neonatal care and other medically relevant studies. He is both a mentor to numerous trainees, students and professionals and at the forefront of Pediatric and Neonatology research and development, saving countless lives and improving the odds for hundreds of infants and mothers. The doctor is a consummate supporter of the community including Greenwood High School Honors Biology Research Program with Becky Kehler (now in Sarasota County Schools, Fla). He worked with the Marion County Prosecutor's Office as a consultant and has supported Johnson County 4-H Fair as a Grand Champion in Artistic Painting. Looking ahead, Dr. Winchester envisions a future filled with continued growth and success in the field of neonatology and pediatrics. He is pursuing the next steps in protecting pregnant women from unwanted chemicals now contaminating them while pregnant. He explained, "our discovery of glyphosate in most pregnant women is just one of a litany of chemicals now found in every life form on the planet. The capacity of these chemicals to alter the DNA of our offspring, inducing diseases across generations, is the next big challenge which we heretofore weren't aware of. Infertility is the worst of these chemicals' effects since it will lead to the inability of the human race to reproduce naturally if not altered." The doctor added that, "the privilege of treating sick newborns comes with the responsibility to find the origin of their diseases: preterm birth, birth defects, fetal growth restriction and their impact of cognitive and physical development of our children. Most chronic diseases today have their origins in ancestral environmental contaminants through epigenetic fetal changes. We are perfecting the means of keeping preterm babies alive, but they should never have to be born premature or sick in the first place. Our next big step is to provide the pharmacological, proteomic, probiotic, nutritional and medical, and psychological means to prepare women and their spouses for an optimal state of health before they become pregnant. This will include chemical surveillance, epigenetic and genetic surveillance and counseling, and may, one day, include modifiers for both genetic and epigenetic risk variants." Dr. Winchester's current primary research focuses on the role that prenatal herbicides impact the pregnancy, fetal development and long-term neuro-psychological development of exposed offspring including the potential role these contaminants have on childhood conditions such as autism spectrum disorder and attention, anxiety, depression disorders. His other research interests also include Physiological Maturation of the Neonate and Readiness for Discharge; III Neonatal Data Systems, Computerization of OB/Neonatal Data Base; and Sleep Study Program at Overland Park Regional Medical Center. Aside from Dr. Winchester's incredible career and influence in the medical field, he is a former athlete excelling in many sports including football where he was an All-State Athlete at Bozeman Senior High School and Division Champion in wrestling for Pacific Coast Small Colleges in 1967 at Lewis and Clark. He grew up on Winchester Angus Cattle Ranch in Bozeman, Montana. The doctor has more than 4 decades of extraordinary experiences, collaborating with national and international professionals. He has lived in Ankara, Turkey, studied in Tours, France and Edinburgh, Scotland, and speaks French, Spanish, and some German. While Dr. Winchester's professional achievements are indeed noteworthy, he considers his most gratifying accomplishment to be the extraordinary success of his four children, 3 grandchildren and counting, and wife, Deb, who remains his most important partner in life. Reflecting on his journey, Dr. Winchester acknowledges the influence of his parents, Burl Winchester and Carolyn Winchester; Mark Winchester MD (brother); Band director Percy Bronson; 4th grade teacher Mrs. Knoll; Wrestling and Football Coach Tom Le Prouse; Bozeman Senior High School; Del Weber, former President of California Teachers Association; Gordon Bower PhD Professor, Stanford University; Cy Gilbert director, Plans Programs American Airlines; Robert Bjork PhD Professor UCLA; Patrick O'Meara MD and Sharon Langendorfer MD at the University of Colorado Medical Center; Thomas Bouchard, University of Minnesota (Minnesota Twin Study); Ernie Beal MD Elliot Hospital; William Edwards MD, Dartmouth Medical School; James Lemons MD, former Chief Division of Neonatology Riley Hospital for Children and Indiana University School of Medicine, and early teachers who encouraged his pursuits. He also pays tribute to Dr. James A. Lemons, MD, the Chair of the Neonatal Department at the Indiana University School of Medicine, as a significant mentor who shaped his career along with his wife, Deb Winchester. Contact: Katherine Green, 516-825-5634, [email protected] SOURCE The Inner Circle WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

IN8bio is putting its brain tumor development program on the back burner and axing almost half of its employees in an effort to cut costs and divert resources to an early-phase blood cancer asset. The New York-based biotech is hitting pause on its 120-patient Phase 2 trial of INB-400 for recurrent or newly diagnosed glioblastoma, which just dosed its first patient in April. IN8bio will stop further recruitment into the study as it searches for “partnership opportunities,” according to a company release Wednesday. As for the Phase 1 trial of INB-200 in newly diagnosed glioblastoma, which has enrolled 21 patients, the company will keep tracking long-term remissions and overall survival. IN8bio will continue monitoring all patients across both studies. The “difficult decision” will allow the company to “reduce our spend and focus on key milestones that can help to generate near-term interest and value creation,” CEO William Ho said in the release. As for IN8bio’s layoffs, it is cutting around 49% of its staffers across all functions. The drugmaker had 39 full-time employees at the end of June, according to an SEC filing from last month. The workforce reduction is expected to cost IN8bio less than half a million dollars. The company ended June with just $10.2 million in cash, according to its latest earnings release . It is cutting executives’ pay by 11%, according to a Wednesday SEC filing . IN8bio says these cuts mean that it would have fuel for its allogeneic gamma delta T cell therapy program for acute myeloid leukemia. The candidate, dubbed INB-100, is being tested in a University of Kansas-sponsored Phase 1 dose-escalation trial in the post-transplant maintenance setting. As of last month, all eight AML patients in the Phase 1 given INB-100 were relapse-free at a median follow-up of 18.7 months. But certain patients in the 38-subject study with other forms of leukemia who relapsed have since died of disease progression. Following a meeting with the FDA, the company plans to add a control group to the study and continue enrolling into the expansion cohort with a target of 25 additional AML patients. It expects to have long-term follow-up results ready late next year and in 2026.